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@ARTICLE{Schlenk:130491,
author = {R. Schlenk$^*$ and M. Lübbert and A. Benner$^*$ and A.
Lamparter and J. Krauter and W. Herr and H. Martin and H. R.
Salih and A. Kündgen and H.-A. Horst and P. Brossart and K.
Götze and D. Nachbaur and M. Wattad and C.-H. Köhne and W.
Fiedler and M. Bentz and G. Wulf and G. Held and B.
Hertenstein and H. Salwender and V. I. Gaidzik and B.
Schlegelberger and D. Weber and K. Döhner and A. Ganser and
H. Döhner},
collaboration = {G. A. M. L. S. Group},
title = {{A}ll-trans retinoic acid as adjunct to intensive treatment
in younger adult patients with acute myeloid leukemia:
results of the randomized {AMLSG} 07-04 study.},
journal = {Annals of hematology},
volume = {95},
number = {12},
issn = {0939-5555},
address = {Berlin},
publisher = {Springer61936},
reportid = {DKFZ-2017-05570},
pages = {1931-1942},
year = {2016},
abstract = {The aim of this clinical trial was to evaluate the impact
of all-trans retinoic acid (ATRA) in combination with
chemotherapy and to assess the NPM1 status as biomarker for
ATRA therapy in younger adult patients (18-60 years) with
acute myeloid leukemia (AML). Patients were randomized for
intensive chemotherapy with or without open-label ATRA
(45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles
of induction therapy were followed by risk-adapted
consolidation with high-dose cytarabine or allogeneic
hematopoietic cell transplantation. Due to the open label
character of the study, analysis was performed on an
intention-to-treat (ITT) and a per-protocol (PP) basis. One
thousand one hundred patients were randomized (556,
STANDARD; 544, ATRA) with 38 patients treated vice versa.
Median follow-up for survival was 5.2 years. ITT analyses
revealed no difference between ATRA and STANDARD for the
total cohort and for the subset of NPM1-mutated AML with
respect to event-free (EFS; p = 0.93, p = 0.17) and
overall survival (OS; p = 0.24 and p = 0.32,
respectively). Pre-specified PP analyses revealed better EFS
in NPM1-mutated AML (p = 0.05) and better OS in the
total cohort (p = 0.03). Explorative subgroup analyses
on an ITT basis revealed better OS (p = 0.05) in ATRA
for genetic low-risk patients according to ELN
recommendations. The clinical trial is registered at
clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).},
keywords = {Tretinoin (NLM Chemicals)},
cin = {G040 / C060 / G100},
ddc = {610},
cid = {I:(DE-He78)G040-20160331 / I:(DE-He78)C060-20160331 /
I:(DE-He78)G100-20160331},
pnm = {317 - Translational cancer research (POF3-317)},
pid = {G:(DE-HGF)POF3-317},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:27696203},
pmc = {pmc:PMC5093206},
doi = {10.1007/s00277-016-2810-z},
url = {https://inrepo02.dkfz.de/record/130491},
}